Protocol 016

OUTLINE OF PROTOCOL 016

A PHASE I, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED HIV-1 CLINICAL TRIAL TO EVALUATE AND COMPARE THE SAFETY AND IMMUNOGENICITY OF MN RGP120/HIV-1 IN COMBINATION WITH QS21 ADJUVANT

Subjects: Healthy, HIV-1 uninfected adult volunteers with lower-risk behavior for HIV-1 infection. [Number of Subjects = 80]

Schema:

GROUP A 0, 1, 10 months [Days 0, 28, 280]
MN rgp120/ HIV-1	QS21 0 µg + alum	QS21 50 µg + alum	QS21 50 µg - alum	QS21 100 µg + alum	QS21 100 µg - alum
0 µg		4 C1		4 C2	4 C3
100 µg	4² T1¹	4 T2	4 T4	4 T3	4 T5
300 µg	4 T6	4 T7	4 T9	4 T8	5² T10
600 µg			4 T11		4 T12
GROUP B 0, 1, 6 months [Days 0, 28, 168]
MN rgp120/ HIV-1	QS21 0 µg + alum	QS21 50 µg + alum	QS21 50 µg - alum	QS21 100 µg + alum	QS21 100 µg - alum
300 µg	4 T13	4 T14	4 T16	4 T15	4 T17

¹ Treatment group code ² Study was overenrolled by one volunteer in this group

ACCRUAL, IMMUNIZATIONS, AND FOLLOW-UP COMPLETED

Product Description: CHO cell-derived HIV-1 MN rsgp120 in combination with QS21 ± alum [Genentech]

Time Period: First volunteer enrolled 06/16/93 and last on 11/10/93; follow-up of 18 months.

Clinical Sites: Johns Hopkins University, Saint Louis University, University of Rochester, University of Washington, Vanderbilt University

Study Chair: Julie McElrath, University of Washington

INCLUSION CRITERIA

Standard inclusion criteria.

EXCLUSION CRITERIA

Standard exclusion criteria.

STUDY GOALS

The primary objectives of this study are to examine the safety and potential improvement in immune responses elicited by combining MN rsgp120/HIV-1 with QS21. The secondary objectives are to examine the role of alum in the vaccine/adjuvant formulation, to determine the optimal dose ratio of vaccine to adjuvant, and to obtain initial information on the optimal schedule of administration.